The EU vision

Prof. Dr. Krzysztof MARUSZEWSKI

Director

Institute for Health and Consumer Protection

(JRC-IHCP)

Joint Research Centre

The European Commission’s

in-house science service

Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission. © European Union, 2013

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The Joint Research Centre within the European Commission

President

José Manuel Barroso

Director-General (Department)

Vladimír Šucha

Joint Research Centre

27 Commission Members

DG Research & Innovation (RTD)

Commissioner

Máire Geoghegan-Quinn

Research, Innovation & Science

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The Joint Research Centre within the European Commission

European

Commission

Directorates

General

Directorates

Institutes

Units

Scientific Units

European Reference

Laboratories,

Centres & Bureaus

JRC

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To provide customer-driven scientific and technical support for the

conception, development, implementation and monitoring of EU policies.

As a service of the European Commission, the JRC functions as a

reference centre of science and technology for the Union.

Close to the policy-making process, it serves the common interest of

the Member States, while being independent of private or national

special interests.

The Mission of the Joint Research Centre

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Institute for Health and Consumer Protection

Public Health

Policy Support

C. Nicholl

Molecular

Biology and

Genomics

J. Kreysa

Nano-

Biosciences

H. Stamm

Systems

Toxicology

M. Whelan

Chemical

Assessment

and Testing

P. Aguar

Director K. Maruszewski

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IHCP Policy Support Areas

Genetically Modified Organisms

Nanotechnology

Public Health

Food and Consumer Products

Chemical Assessment &

Alternatives to Animal Testing

Healthcare Quality

Nutrition

Disease registries

Behavioural Sciences

Medical Devices

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AIM: To provide women with a high degree of confidence and assurance

in all processes directly concerning them in relation to all stages of breast

cancer care, via:

1 - the establishment of a platform of evidence (guidelines – A PRIORITY)

2 - based on such platform, the implementation and monitoring (auditing)

of a European set of quality standards

METHOD: draft proposals – open consultation – consensus

(TRANSPARENCY – INCLUSIVENESS – PEER EVALUATION)

TIME FRAME: project completion due by 2016 (guidelines, QA scheme

pilot, web-hub).

EC Initiative on Breast Cancer: Aim – Method – Timeframe

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Breast cancer initiative: objectives

Development and publication of web-based and evidence based New

European Guidelines for Breast Cancer Screening and Diagnosis.

Development of a European Quality Assurance (QA) Scheme

for Breast Cancer Services, underpinned by the EU’s legal framework

of accreditation and by a set of evidence-based guidelines.

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Treaty of Lisbon (Title XIV, Article 168) "The Commission may, in close

contact with the Member States, take any useful initiative […] aiming at the

establishment of guidelines and indicators, the organisation of

exchange of best practice, and the preparation of the necessary

elements for periodic monitoring and evaluation’’’

European Parliament resolution of 2003 on breast cancer "Calls on

the Member States and on the Commission to make the fight against breast

cancer a health policy priority and to develop and implement effective

strategies for improved preventive health care" and "calls on the Member

States, therefore, to establish a network of certified multidisciplinary

breast centres"

Background for the EC initiative on BC (1)

Breast cancer in 2012 (year of latest observations) is still by far the

most deadly cancer affecting women every year, with an average of

22,4/100 000 (15,1 -> 29,5) women dying of breast cancer in the EU

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Council Recommendation in 2003 for cancer screening in

accordance with the European Guidelines

European Parliament Resolution of April 2008 acknowledges

“…unacceptable differences (between Member States) in the quality

of cancer treatment facilities…”

the Council Conclusions of June 2008 invite the Commission to “explore

the potential for the development of voluntary European accreditation

schemes for cancer screening and appropriate follow-up of lesions detected

by screening […]” and to “facilitate the development and updating of […]

web-based quality assurance and evidence-based guidelines on cancer […]”

Background for the EC initiative on BC (2)

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European Institutions are active in this area since 1987:

Since 1993 European guidelines for quality assurance (QA) in breast cancer

screening and diagnosis were supported by the European Commission (four

editions so far).

They were essential for the development of screening programmes in

Europe.

• 4th edition issued in 2006.

• Supplements just published; coordinated by the same Editorial Board.

It is the main basis for the

EUROPA DONNA

Guide to Breast Health

Guidelines

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Many schemes active in Europe (private and public)

• EUSOMA - ECCC (Breast Units concept – multidisciplinarity)

• DKG – DGS (dual certification process coupled to S3 guidelines)

• EUREF (diagnostic breast imaging and breast screening services)

• OECI (accreditation & designation programme for cancer centres)

• SIS – ISS (accreditation program for breast centres / units)

• National Institute for Cancer and French Ministry of Health (Cancer

treatment authorisation) - FR

• Health Information and Quality Authority (National Quality Assurance

Standards for Symptomatic Breast Disease Services) – IE

• Royal Decree for accreditation of Breast Cancer Care Programs - BE

Essential requirements selected considering those already in use

(databases not to be reinvented)

QA schemes

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Via Commission Implementing Decision of 1 December 2011 JRC is asked

to coordinate the European Commission Initiative on Breast Cancer,

constituted by the two main pillars, Guidelines and QA scheme.

JRC concept: Guidelines underpin the QA scheme and their application is

enhanced by the QA scheme

JRC provides:

- Sustainable / long-term organisational framework

- Transparent platform for stakeholders involvement

- A platform for consultation and feed-back collection on Initiative's

documents

The EC initiative on BC

JRC will build on past and on-going experiences

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Guidelines

Systematically developed statements to assist practitioner and patient

decisions about appropriate healthcare.1 [and support policy makers]

Evidence-based guidelines are essential for the QA Scheme.

Quality Assurance Scheme

Quality requirements for clinical aspects should correspond to key

recommendations from guidelines, supported by the best available

evidence.

1 Field MJ, Lohr KN, editors; Committee to Advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine. Clinical practice guidelines: directions of a new program. Washington, DC: National Academy Press; 1990

Guidelines go hand in hand with QA scheme

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The what / the how

1. The EC aims proposing requirements applicable by all countries

and impacting on quality of care in a reasonable timeframe

2. The JRC, in its role of providing scientific evidence to policies, will

coordinate the development of the platform of evidence and its

use for underpinning the QA scheme requirements

3. Based on evidence and new available technologies, countries'

might decide on which model to apply in order to attain those

requirements

To conclude:

EC suggests and support with evidence the set of essential QA scheme

requirements

Countries implement them in total autonomy (according to treaties)

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1a. The New European Guidelines for Breast Cancer Screening and

Diagnosis.

1b. A platform of high quality guidelines for the QA scheme for stages

not covered in the revised version of European Guidelines.

2. A sustainable maintenance process for the guidelines and the QA

scheme.

3. A set of Key Performance Indicators (KPIs)

4. A pilot European quality assurance (QA) scheme,

accreditation underpinned by the European legislative framework

for breast cancer services.

Breast Cancer Initiative: Expected outcomes (1)

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Breast Cancer Initiative: Expected outcomes (2)

5. Tools for identifying reference documents for Guideline and

Scheme users

QA Guidelines, Technical Annexes, Best Practices, Implementation

Examples, Guiding Documents, Training Documents (for auditors

and auditees), Decision Aids (for professionals and for patients).

6. A web-hub hosting all the outcomes (targeted users/targeted

objects).

If this concept proves to be successful, JRC would provide support for its

application for other healthcare areas.

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Website

http://ihcp.jrc.ec.europa.eu/our_activities/public-health/cancer_policy_support

Email

jrc-cancer-policy-support@ec.europa.eu

For more information

Thank You for Your Attention

© European Union, 2013 Disclaimer: The contents of this presentation are the views of the author and do not necessarily represent an official position of the European Commission.

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1. Woman/patient is at the centre of the process

2. ONE set of guidelines for screening and diagnosis for Europe

3. Controlled criteria for the selection of guidelines for other stages

4. ONE scheme publicly available for all Europe ensuring that

guidelines are applied and essential requirements are fulfilled

Breast Cancer Initiative: DESIRABLE (1)

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5. KPI monitoring – KPI stability (quality requirements vs. target

case volumes?)

6. Up to date: New remote technologies, genetic testing, delocalised

care for certain stages

7. Modular with strong interface requirements (applicable to all

organisational frames in Member States)

8. NOT endangering existing (national & private) schemes

9. Sustainable (ex-ante evaluation, health economy tools for countries)

Breast Cancer Initiative: DESIRABLE (2)

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1. Inequality across countries.

2. No evidence supporting choice of essential requirements

from guidelines.

3. Opportunistic screening.

4. Opportunistic treatment.

5. Multiplication of schemes (not under Health Authorities control

– not understandable by women).

6. Increased costs.

Breast Cancer Initiative: NOT DESIRABLE

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a. A database of existing networks, projects, entities.

b. Knowledge platform (>1000 papers collected and organised).

c. A survey on screening & organisation of breast cancer services.

d. A study on existing QA schemes (23 detected in Europe).

e. A short questionnaire on the application of European QA Guidelines

in European countries.

f. A review of validated questionnaires used to collect feed-back on

satisfaction of women receiving BC screening.

BC Initiative preparation (1)

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g. Bilateral meetings with key stakeholders.

h. Two workshops (WSs) at the beginning of 2013 to present

the project concept and to obtain consensus.

i. A concept document describing the objectives and a proposed

working modality.

j. Web-hub conceptualisation.

BC Initiative preparation (2)

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Guidelines: Systematically developed statements to assist practitioner

and patient decisions about appropriate healthcare.

Concept after WSs conclusions

Guidelines

1. SCREENING

2. DIAGNOSIS

3. TREATMENT

4. REHABILITATION

5. FOLLOW-UP

THE 5th

edition of

EUROPEAN

GUIDELINES

PLATFORM of

HIGH QUALITY

GUIDELINES

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Concept after WSs conclusions

QA scheme

3. TREATMENT 5. FOLLOW-UP 4. REHABILITATION 1. SCREENING 2. DIAGNOSIS

Covered by Regulation (EC) No 765/2008 and including:

1 - Quality Management (ISO 9001 / CEN 15224)

2 – Testing activities (ISO 15189 / 17025 /12052 – digital imaging)

3 – Data collection (KPI, quality checks from ENCR, relevant ISO standards)

4 - Patient Safety (Directive 2011/24/EU & Council Recommendation of 2009)

5 - Specific requirements from Guidelines and Experts (all stages of care)